Analyte concentration alert function for analyte sensor system

ABSTRACT

Systems, methods, and apparatuses that provide alerts based on analyte data and acceleration data. An analyte sensor may generate the analyte data. An accelerometer may generate the acceleration data. A transceiver may convert the analyte data into analyte concentration values. The transceiver may convert the acceleration data into activity information. The transceiver may generate an alert based on the analyte concentration values and activity information. The alert may be communicated to a user by a mobile medical application executed on the transceiver and/or a display device (e.g., smartphone) in communication with the transceiver. The mobile medical application may display (e.g., on a display of the display device) a plot or graph of the analyte concentration values and activity information with respect to time.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/485,410, filed on Apr. 12, 2017, which is a divisional ofU.S. patent application Ser. No. 14/559,238, filed on Dec. 3, 2014, nowU.S. Pat. No. 10,327,714, all of which are incorporated by reference intheir entireties. U.S. patent application Ser. No. 14/559,238 claims thebenefit of priority to (1) U.S. Provisional Application Ser. No.61/912,103, filed on Dec. 5, 2013, and (2) U.S. Provisional ApplicationSer. No. 61/922,387, filed on Dec. 31, 2013, all of which areincorporated by reference in their entireties. U.S. patent applicationSer. No. 14/559,238 is a continuation-in-part of U.S. patent applicationSer. No. 14/453,078, filed on Aug. 6, 2014, now U.S. Pat. No.10,111,588, which claims the benefit of priority to (1) U.S. ProvisionalApplication Ser. No. 61/864,174, filed on Aug. 9, 2013, (2) U.S.Provisional Application Ser. No. 61/865,373, filed on Aug. 13, 2013, and(3) U.S. Provisional Application Ser. No. 61/881,679, filed on Sep. 24,2013, all of which are incorporated by reference in their entireties.U.S. patent application Ser. No. 14/453,078 is (1) acontinuation-in-part of U.S. patent application Ser. No. 13/937,871,filed on Jul. 9, 2013, now U.S. Pat. No. 9,414,775, and (2) acontinuation-in-part of U.S. patent application Ser. No. 13/853,095,filed on Mar. 29, 2013, now U.S. Pat. No. 9,345,426, which claims thebenefit of priority to U.S. Provisional Application Ser. No. 61/617,414,filed on Mar. 29, 2012, all of which are incorporated by reference intheir entireties.

BACKGROUND Field of Invention

The present invention relates generally to an analyte concentrationalert function for an analyte sensor system. Specifically, the presentinvention relates to a hypoglycemia alert function for a glucose sensorsystem that generates an alert based on acceleration data.

Discussion of the Background

Diabetes is a metabolic disease in which the body's inability to produceany or enough insulin causes elevated levels of glucose in the blood.Treatment for diabetes includes oral medications and injection orinfusion of basal and/or bolus insulin. People with diabetes have anincreased risk of hypoglycemia.

Hypoglycemia is defined as a condition characterized by abnormally lowblood glucose levels, usually less than 70 mg/dL. Hypoglycemia can alsoinclude conditions when the blood glucose of any individual abruptlykeeps dropping and goes below a certain threshold (e.g., 70 mg/dL). Themost common reasons leading to hypoglycemia in patients includeinjecting a dose of insulin (e.g., a meal bolus) and then skipping ameal, overdosing on insulin (e.g., through too many injections orthrough an insulin pump), or strenuous activity (e.g., running orexercising). There are a number of symptoms associated with hypoglycemia(e.g., seizures, etc.). However, a number of people with diabetes eitherdo not exhibit symptoms or are otherwise unaware of their hypoglycemia,a condition known as hypoglycemia unawareness. If left untreated,hypoglycemia has the potential to lead to fatal situations, such asaccidents, injuries, unconsciousness, seizures, coma, and, in somecases, death.

Typically, hypoglycemia is treated with the consumption of carbohydratesto restore blood glucose to safe levels and prevent the progression tosevere hypoglycemia. People with diabetes need to maintain a log of theamount of daily carbohydrates consumed in order to adequately treattheir diabetes. Errors in carbohydrate counting can lead tomiscalculated doses of insulin which in turn can lead to hypoglycemia.In severe cases of hypoglycemia (e.g. during seizures and/orunconsciousness) an emergency injection of the hormone glucagon may berequired (i.e. a glucagon rescue) to raise the blood glucose to a safelevel.

Although some continuous glucose monitors (CGMs) alert users whennegative glucose trends are detected and alarm users when the bloodglucose falls below a user-defined threshold, these alerts are providedto users when the patient is already hypoglycemic or about just about tobe hypoglycemic.

There is presently a need in the art for a continuous analyte monitorwith an improved hypoglycemic alert function.

SUMMARY

One aspect of the invention may provide a method of alerting for acurrent or projected physiological condition or reaction. In someembodiments, the method may comprise generating acceleration datacorresponding to movement of an accelerometer, generating activityinformation based on the acceleration data, and generating an alert forthe current or projected physiological condition or reaction based onthe activity information. In some embodiments, the method may furthercomprise displaying the alert. The display of the alert may be by amobile medical application executed by a processor of, for example, adisplay device. In some embodiments, the display device may be, forexample, a smartphone. In some embodiments, the accelerometer may belocated, for example, within a transceiver, an analyte sensor and/or anactivity tracker. In some embodiments, the physiological condition orreaction may be, for example, hypoglycemia, dehydration and orhyperglycemia. In some embodiments, the alert may be a predictive alert.

In other embodiments, the method may further comprise receiving galvanicor physiologic measurements from an on-body or within body sensor,wherein the activity information is generated based on the accelerationdata and the galvanic or physiologic measurements. In embodimentswherein the accelerometer is located in a transceiver, the method mayfurther comprise receiving activity information from an activitytracker, and wherein the alert is additionally based on the activityinformation received from the activity tracker. In some embodiments, themethod may comprise generating analyte concentration values based ondata signals received from an analyte sensor, wherein generating thealert comprises generating the alert based on the activity informationand the analyte concentration values.

In some embodiments, the method may comprise displaying a plot of theanalyte concentration values and the activity information with respectto time. In some embodiments, the plot may be generated by a mobilemedical application executed by a processor of a display device, and theplot may be displayed on a display of the display device. In someembodiments, the method may comprise using a transceiver to receive thedata signals from the analyte sensor, and using the transceiver togenerate the analyte concentration values. In some embodiments, themethod may comprise using the transceiver to convey the data signals toa display device, and using a mobile medical application executed by aprocessor of the display device to generate the analyte concentrationvalues.

In some embodiments, generating activity information based on theacceleration information may comprise converting the acceleration datainto scalar acceleration values, comparing the scalar accelerationvalues to an activity threshold, and generating activity informationbased on the frequency of acceleration values that exceed the activitythreshold. In some embodiments, the activity information may be used todetect sleep patterns and/or to detect step counts. In some embodiments,generating activity information based on the acceleration informationmay comprise converting the acceleration data into scalar accelerationvalues, comparing the scalar acceleration values to an activitythreshold, and generating activity information based on the frequency ofacceleration values that exceed the activity threshold. In someembodiments, a transceiver may be used to generate the activityinformation.

In some embodiments, a mobile medical application executed by aprocessor of a display device may be used to generate the activityinformation and/or generate the alert. In some embodiments, atransceiver may be used to receive the generated activity informationand/or to generate the alert.

In another aspect of the invention, a system may be provided whichcomprises an accelerometer configured to generate acceleration datacorresponding to movement of the accelerometer, and a transceiverconfigured to generate or receive activity information based on theacceleration data and to generate an alert for a current or projectedphysiological condition or reaction based on the activity information.In some embodiments, the transceiver may comprise the accelerometer.Some embodiments may comprise an analyte sensor where in the analytesensor comprises the accelerometer. In some embodiments, the transceiveris configured to receive data signals from the analyte sensor, generateanalyte concentration values based on the received data signals, andgenerate the alert based on the analyte concentration values, and theactivity information.

In some embodiments, the system comprises a display configured todisplay the analyte concentration values and the activity informationwith respect to time. In some embodiments, the display is configured todisplay a plot or graph of the analyte concentration values and theactivity information with respect to time. In some embodiments, thedisplay device may include a transceiver interface device configured toreceive the alert, the analyte concentration values, and the activityinformation from the transceiver; a processor configured to execute amobile medical application configured to generate a display of thealert, the analyte concentration values, and the activity information;and a display configured to display the generated display.

In some embodiments, to generate the activity information based on theacceleration data, the transceiver may be configured to convert theacceleration data into scalar acceleration values, compare the scalaracceleration values to an activity threshold, and generate activityinformation based on the frequency of acceleration values that exceedthe activity threshold. In some embodiments, the system may comprise anactivity tracker, wherein the activity tracker comprises theaccelerometer. In some embodiments, the transceiver may comprise theaccelerometer and may be further configured to receive activityinformation from the activity tracker, and generate the alert based on(i) the activity information generated by the transceiver and (ii) theactivity information received from the activity tracker. In someembodiments, the transceiver may be further configured to receivegalvanic or physiologic measurements from an on-body or within bodysensor, and generate the activity information based on the accelerationdata and the galvanic or physiologic measurements.

In another aspect of the invention, an apparatus may be provided whichcomprises a sensor interface device configured to receive data signalsfrom an analyte sensor; an accelerometer configured to generateacceleration data corresponding to movement of the accelerometer; andcircuitry configured to generate analyte concentration values based onthe received data signals, generate activity information based on theacceleration data, and generate an alert based on the analyteconcentration values and the activity information. In some embodiments,the apparatus may comprise an interface device configured to receiveanalyte concentration values and activity information, circuitryconfigured to generate a plot of the analyte concentration values andthe activity information with respect to time, and a display configuredto display the plot.

In another aspect of the invention, a method may be provided foralerting for a current or projected physiological condition or reactionbased on informatics generated by accelerometer measurements.

Further variations encompassed within the systems and methods aredescribed in the detailed description of the invention below.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and form partof the specification, illustrate various, non-limiting embodiments ofthe present invention. In the drawings, like reference numbers indicateidentical or functionally similar elements.

FIG. 1 is a schematic view illustrating an analyte monitoring systemembodying aspects of the present invention.

FIG. 2 is a schematic view illustrating a transceiver embodying aspectsof the present invention.

FIG. 3 is a flow chart illustrating an alerting process embodyingaspects of the present invention.

FIG. 4 is a flow chart illustrating an activity information generationprocess embodying aspects of the present invention.

FIG. 5 is a graph showing scalar acceleration values measured by asystem embodying aspects of the present invention.

FIG. 6 is a graph showing the intensity and duration of the physicalactivity of a patient measured by a system embodying aspects of thepresent invention.

FIG. 7 is a graph showing the glucose and activity measurements measuredby a system embodying aspects of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 is a schematic view of a continuous analyte monitoring system 120embodying aspects of the present invention. In some embodiments, thesystem 120 may include one or more of an analyte sensor 100, atransceiver 101, a display device 102, and an activity tracker 110. Insome embodiments, the sensor 100 and transceiver 101 may include one ormore of the structural and/or functional features described in one ormore of U.S. Patent Application Publication No. 2013/0241745; U.S.Patent Application Publication No. 2013/0211213; U.S. application Ser.No. 14/453,078; and U.S. Patent Application Publication No.2014/0018644; all of which are incorporated by reference in theirentireties.

In some embodiments, system 120 may include one or more accelerometers(e.g., accelerometer 105 and/or accelerometer 111), which may be, forexample, 3D accelerometers. In some embodiments, the one or moreaccelerometers may be configured to generate acceleration datacorresponding to movement of the accelerometer. In some embodiments, thecontinuous analyte monitoring system 120 may use the one or moreaccelerometers to keep track of near continuous movements of a user'supper arm, wrist, leg, or core, for example. In some embodiments, theone or more accelerometers may be located in or part of one or more ofthe analyte sensor 100, transceiver 101, display device 102, andactivity tracker 110. In some non-limiting embodiments, as illustratedin FIG. 1, the transceiver 101 may include an accelerometer 105. In somenon-limiting embodiments, as illustrated in FIG. 1, the system 120 mayinclude an activity tracker 110 (e.g., an on-body activity tracker suchas, for example and without limitation, a fitbit), which may include anaccelerometer 111 in addition to or as an alternative to theaccelerometer 105. In some non-limiting embodiments, the analyte sensor100 and/or display device 102 may additionally or alternatively includean accelerometer. In some embodiments, the transceiver 101 may beconfigured to generate activity information based on acceleration datagenerated by one or more accelerometers and may be configured togenerate one or more alerts based on the activity information. In someembodiments, the transceiver 101 may be configured to additionally oralternatively receive activity information (e.g., from display device102 or activity tracker 110) that was generated (e.g., by display device102 or activity tracker 110) based on acceleration data generated by oneor more accelerometers. In some embodiments, the transceiver 101 and/ordisplay device 102 may communicate the one or more alerts to a user. Insome embodiments, the alerts may be visual, audible, and/or vibratoryalerts.

In some embodiments, the transceiver 101 may be configured to receivedata signals from the analyte sensor 100 and may be configured togenerate analyte concentration values based on the received datasignals. In some embodiments, the transceiver 101 may be configured togenerate one or more alerts based on the analyte concentration valuesand the activity information. In some embodiments, the system 120 mayinclude one or more displays. For example, in one non-limitingembodiment, the system 120 may include a display device 102, and thedisplay device 102 may include a display 108 configured to display(e.g., in a plot or graph) one or more of the analyte concentrationvalues and the activity information with respect to time. In someembodiments, the transceiver 101 may additionally or alternativelyinclude a display configured to display one or more of the analyteconcentration values and the activity information with respect to time.

In some embodiments, the analyte sensor 100 may include sensor elements112 and a transceiver interface device 103. The sensor elements 112 maybe configured to detect the presence and/or concentration of an analyte(e.g., glucose, oxygen, cardiac markers, low-density lipoprotein (LDL),high-density lipoprotein (HDL), or triglycerides). In some non-limitingembodiments, the sensor elements 112 may include one or more of ananalyte indicator, a light source configured to emit excitation light tothe analyte indicator, and a photodetector configured to receive lightfrom the analyte indicator. The amount of light received by thephotodetector may be indicative of the presence or concentration of theanalyte. Although, in some embodiments, as described above, the analytesensor 100 may be an electro-optical sensor, this is not required, and,in some alternative embodiments, the analyte sensor 100 may be anothertype of analyte sensor, such as, for example and without limitation, anelectro-chemical sensor.

In some embodiments, the transceiver interface device 103 may beconfigured to (i) receive a power signal and generate power for poweringthe sensor elements 112 and/or (ii) convey data signals generated by thesensor elements 112. In some non-limiting embodiments, the transceiverinterface device 103 may be configured to wirelessly convey datasignals, and the transceiver interface device 103 may include aninductive element (e.g., an antenna or coil). In some alternativeembodiments, the transceiver interface device 103 may be configured toconvey data signals via a wired connection to an external device (e.g.,transceiver 101), and the transceiver interface device 103 may includethe wired connection.

In some non-limiting embodiments, the analyte sensor 100 may be animplantable sensor or a transcutaneous sensor. In some embodiments, thesensor 100 may be implanted or inserted in a living animal (e.g., aliving human). The sensor 100 may be implanted or inserted, for example,in a living animal's arm, wrist, leg, abdomen, peritoneum,intravenously, or other region of the living animal suitable for sensorimplantation or insertion. For example, in one non-limiting embodiment,the sensor 100 may be implanted beneath the skin (i.e., in thesubcutaneous or peritoneal tissues) such that no portion of the sensor100 protrudes from the skin, and the transceiver interface device 103may convey data signals wirelessly. Although, in some embodiments, theanalyte sensor 100 may be a fully implantable sensor, this is notrequired, and, in some alternative embodiments, the sensor 100 may be atranscutaneous sensor having a wired connection to the transceiver 101.For example, in some alternative embodiments, the sensor 100 may belocated in or on a transcutaneous needle (e.g., at the tip thereof). Inthese embodiments, instead of wirelessly communicating (e.g., usinginductive elements), the sensor 100 and transceiver 101 may communicateusing one or more wires connected between the transceiver 101 and thetranscutaneous needle that includes the sensor 100. For another example,in some alternative embodiments, the sensor 100 may be located in acatheter (e.g., for intravenous blood glucose monitoring) and maycommunicate (wirelessly or using wires) with the transceiver 101.

In some embodiments, the transceiver 101 may be an electronic devicethat communicates with the sensor 100 to power the sensor 100 and/orreceive data signals (e.g., photodetector and/or temperature sensorreadings) from the analyte sensor 100. In some embodiments, thetransceiver 101 may include a sensor interface device 104. The sensorinterface device 104 of the transceiver 101 may be configured to receivethe data signals from the analyte sensor 100 using wireless (e.g.,inductive) and/or wired communication. In some embodiments where datasignals are wirelessly conveyed between the transceiver 101 and theanalyte sensor 100, the communication between the transceiver 101 andthe analyte sensor 100 may be, for example and without limitation, nearfield communication.

In some embodiments (e.g., embodiments in which the sensor 100 is afully implantable sensor), the transceiver 101 may implement a passivetelemetry for communicating with the implantable sensor 100 via aninductive magnetic link for one or more of power and data transfer. Insome embodiments, the magnetic transceiver-sensor link can be consideredas “weakly coupled transformer” type. The magnetic transceiver-sensorlink may provide energy and a link for data transfer using amplitudemodulation (AM). Although in some embodiments, data transfer is carriedout using AM, in alternative embodiments, other types of modulation maybe used. In some non-limiting embodiments, the analyte monitoring systemmay use a frequency of 13.56 MHz, which can achieve high penetrationthrough the skin and is a medically approved frequency band, for powerand/or data transfer. However, this is not required, and, in otherembodiments, one or more different frequencies may be used for poweringand communicating with the sensor 100.

In some non-limiting embodiments, the transceiver 101 may be a handheldtransceiver or a body-worn transceiver (e.g., a transceiver held inplace by a wristwatch, an armband, belt, or adhesive). For example, insome embodiments where the transceiver 101 is an on-body/wearabledevice, the transceiver 101 may be held in place by a band (e.g., anarmband or wristband) and/or adhesive (e.g., as part of a biocompatiblepatch), and the transceiver 101 may convey (e.g., periodically, such asevery two minutes, and/or upon user initiation) measurement commands(i.e., requests for measurement information) to the sensor 100. In someembodiments where the transceiver 101 is a handheld device, positioning(i.e., hovering or swiping/waving/passing) the transceiver 101 withinrange over the sensor implant site (i.e., within proximity of the sensor100) may cause the transceiver 101 to automatically convey a measurementcommand to the sensor 100 and receive a reading from the sensor 100.

In some embodiments, the transceiver 101 may calculate analyteconcentrations from the analyte data received from the sensor 100.However, it is not required that the transceiver 101 perform the analyteconcentration calculations itself, and, in some alternative embodiments,the transceiver 101 may instead convey/relay the analyte data receivedfrom the sensor 100 to another device (e.g., display device 105) forcalculation of analyte concentrations (e.g., by a mobile medicalapplication executing on the display device 105). In some non-limitingembodiments, the analyte concentration calculation may include one ormore features described in U.S. Patent Application Publication No.2014/0018644, which is incorporated by reference in its entirety.

In some embodiments, the transceiver 101 may include a display interfacedevice 106 configured to convey information (e.g., alerts and/or analyteconcentrations) to one or more display devices 102. In some embodiments,a display device 102 may be a portable and/or handheld device. In someembodiments, the display device 105 may be a smartphone. However, thisis not required, and, in alternative embodiments, the display device 102may be a laptop computer, tablet, notebook, personal data assistant(“PDA”), personal computer, or a dedicated analyte monitoring displaydevice. In some embodiments, the display device 102 may include atransceiver interface device 107, which may be configured to communicatewith the display interface device 106 of the transceiver 101 through awired or wireless connection. In some embodiments, the display device102 may include a processor 109, and the display device 102 may have amobile medical application installed thereon. In some non-limitingembodiments, the processor 109 may execute the mobile medicalapplication.

FIG. 2 is a schematic view of a transceiver 101 according to anon-limiting embodiment. In some embodiments, the display interfacedevice 106 of the transceiver 101 may include an antenna of a wirelesscommunication integrated circuit (IC) 910 and/or a connector 902. Insome non-limiting embodiments, the display interface device 106 mayadditionally include the wireless communication IC 910 and/or aconnector IC 904.

In some embodiments, the connector 902 may be, for example, aMicro-Universal Serial Bus (USB) connector. The connector 902 may enablea wired connection to an external device, such as a display device 102(e.g., a smartphone or a personal computer). The transceiver 101 mayexchange data to and from the external device through the connector 902and/or may receive power through the connector 902. The connector IC 904may be, for example, a USB-IC, which may control transmission andreceipt of data through the connector 902. The transceiver 101 may alsoinclude a charger IC 906, which may receive power via the connector 902and charge a battery 908 (e.g., lithium-polymer battery). In someembodiments, the battery 908 may be rechargeable, may have a shortrecharge duration, and/or may have a small size.

In some embodiments, the transceiver 101 may include one or moreconnectors in addition to (or as an alternative to) Micro-USB connector904. For example, in one alternative embodiment, the transceiver 101 mayinclude a spring-based connector (e.g., Pogo pin connector) in additionto (or as an alternative to) Micro-USB connector 904, and thetransceiver 101 may use a connection established via the spring-basedconnector for wired communication to a display device 105 (e.g., asmartphone or a personal computer) and/or to receive power, which may beused, for example, to charge the battery 908.

In some embodiments, the wireless communication IC 910 may enablewireless communication with an external device, such as, for example,one or more display devices 105 (e.g., a smartphone or personalcomputer). In one non-limiting embodiment, the wireless communication IC910 may employ one or more wireless communication standards towirelessly transmit data. The wireless communication standard employedmay be any suitable wireless communication standard, such as an ANTstandard, a Bluetooth standard, or a Bluetooth Low Energy (BLE) standard(e.g., BLE 4.0). In some non-limiting embodiments, the wirelesscommunication IC 910 may be configured to wirelessly transmit data at afrequency greater than 1 gigahertz (e.g., 2.4 or 5 GHz). In someembodiments, the wireless communication IC 910 may include an antenna(e.g., a Bluetooth antenna).

In some embodiments, the transceiver 101 may include voltage regulators912 and/or a voltage booster 914. The battery 908 may supply power (viavoltage booster 914) to radio-frequency identification (RFID) reader IC916, which uses an inductive element 919 to convey information (e.g.,commands) to the sensor 100 and receive information (e.g., measurementinformation) from the sensor 100. In some non-limiting embodiments, thesensor 100 and transceiver 101 may communicate using near fieldcommunication (NFC) (e.g., at a frequency of 13.56 MHz). In theillustrated embodiment, the inductive element 919 is a flat antenna. Insome non-limiting embodiments, the antenna may be flexible. However, theinductive element 919 of the transceiver 101 may be in any configurationthat permits adequate field strength to be achieved when brought withinadequate physical proximity to the inductive element 114 of the sensor100. In some embodiments, the transceiver 101 may include a poweramplifier 918 to amplify the signal to be conveyed by the inductiveelement 919 to the sensor 100.

The transceiver 101 may include a peripheral interface controller (PIC)microcontroller 920 and memory 922 (e.g., Flash memory), which may benon-volatile and/or capable of being electronically erased and/orrewritten. The PIC microcontroller 920 may control the overall operationof the transceiver 101. For example, the PIC microcontroller 920 maycontrol the connector IC 904 or wireless communication IC 910 totransmit data via wired or wireless communication and/or control theRFID reader IC 916 to convey data via the inductive element 919. The PICmicrocontroller 920 may also control processing of data received via theinductive element 919, connector 902, or wireless communication IC 910.

In some embodiments, the transceiver 101 may include a sensor interfacedevice, which may enable communication by the transceiver 101 with asensor 100. In some embodiments, the sensor interface device may includethe inductive element 919. In some non-limiting embodiments, the sensorinterface device may additionally include the RFID reader IC 916 and/orthe power amplifier 918. However, in some alternative embodiments wherethere exists a wired connection between the sensor 100 and thetransceiver 101 (e.g., transcutaneous embodiments), the sensor interfacedevice may include the wired connection.

In some embodiments, the transceiver 101 may include a display 924(e.g., liquid crystal display and/or one or more light emitting diodes),which PIC microcontroller 920 may control to display data (e.g., glucoseconcentration values). In some embodiments, the transceiver 101 mayinclude a speaker 926 (e.g., a beeper) and/or vibration motor 928, whichmay be activated, for example, in the event that an alarm condition(e.g., detection of a hypoglycemic or hyperglycemic condition) is met.The transceiver 101 may also include one or more additional sensors 930,which may include an accelerometer (e.g., accelerometer 105) and/ortemperature sensor, that may be used in the processing performed by thePIC microcontroller 920.

In some embodiments, the transceiver 101 may be a body-worn transceiverthat is a rechargeable, external device worn over the sensorimplantation or insertion site. The transceiver 101 may supply power tothe proximate sensor 100, calculate analyte concentrations from datareceived from the sensor 100, and/or transmit the calculated analyteconcentrations to a display device 105 (see FIGS. 1A, 1B, and 5). Powermay be supplied to the sensor 100 through an inductive link (e.g., aninductive link of 13.56 MHz). In some embodiments, the transceiver 101may be placed using an adhesive patch or a specially designed strap orbelt. The external transceiver 101 may read measured analyte data from asubcutaneous sensor 100 (e.g., up to a depth of 2 cm or more). Thetransceiver 101 may periodically (e.g., every 2 minutes) read sensordata and calculate an analyte concentration and an analyte concentrationtrend. From this information, the transceiver 101 may also determine ifan alert and/or alarm condition exists, which may be signaled to theuser (e.g., through vibration by vibration motor 928 and/or an LED ofthe transceiver's display 924 and/or a display of a display device 105).The information from the transceiver 101 (e.g., calculated analyteconcentrations, calculated analyte concentration trends, alerts, alarms,and/or notifications) may be transmitted to a display device 105 (e.g.,via Bluetooth Low Energy with Advanced Encryption Standard (AES)-CounterCBC-MAC (CCM) encryption) for display by a mobile medical application onthe display device 105. In some non-limiting embodiments, the mobilemedical application may provide alarms, alerts, and/or notifications inaddition to any alerts, alarms, and/or notifications received from thetransceiver 101. In one embodiment, the mobile medical application maybe configured to provide push notifications. In some embodiments, thetransceiver 101 may have a power button (e.g., button 208) to allow theuser to turn the device on or off, reset the device, or check theremaining battery life. In some embodiments, the transceiver 101 mayhave a button, which may be the same button as a power button or anadditional button, to suppress one or more user notification signals(e.g., vibration, visual, and/or audible) of the transceiver 101generated by the transceiver 101 in response to detection of an alert oralarm condition.

In some embodiments, the transceiver 101 may provide on-body alerts tothe user in a visual, audible, and/or vibratory manner, regardless ofproximity to a display device 105. In some non-limiting embodiments, asillustrated in FIG. 2, the transceiver 101 may include one or morenotification devices (e.g., display 924, beeper 926, and/or vibrationmotor 928) that generate visual, audible, and/or vibratory alerts. Insome embodiments, the transceiver 100 may be configured to vibrateand/or generate an audio or visual signal to prompt the user aboutanalyte readings outside an acceptable limit, such as hypo/hyperglycemic alerts and alarms in the case where the analyte is glucose.

In some embodiments, the transceiver 101 may store the measurementinformation received from the sensor 100 (e.g., in memory 922). Themeasurement information received from the sensor 100 may include one ormore of: (i) a signal channel measurement with a light source on, (ii) areference or second signal channel measurement with the light source on,(iii) a light source current source voltage measurement, (iv) a fieldcurrent measurement, (v) a diagnostic measurement, (vi) an ambientsignal channel measurement with the light source off, (vii) an ambientreference or second signal channel measurement with the light sourceoff, and (viii) a temperature measurement. In some embodiments, thetransceiver 101 may additionally store (e.g., in memory 922) other datawith the measurement information received from the sensor 100. In somenon-limiting embodiments, the other data may include one or more of: (i)an analyte concentration (e.g., in mg/dL, such as, for example, within arange of 20.0 to 400.0 mg/dL) calculated by the transceiver 101 from themeasurement information, (ii) the date and time that the analytemeasurement was taken, (iii) accelerometer values (e.g., x, y, and z)taken from an accelerometer (e.g., accelerometer 105 of the transceiver101 and/or accelerometer 111 of the activity tracker 110), and/or (iv)the temperature of the transceiver 101 as measured by a temperaturesensor of the transceiver 101. In some embodiments, the transceiver 101may keep track of the date and time and, as noted above, store the dateand time along with the received analyte measurement information and/oranalyte concentrations.

In embodiments where the transceiver 101 includes an accelerometer, theaccelerometer will enable tracking of activity levels of the subjectthat is wearing the transceiver 101. This activity level may be includedin an event log and incorporated into various algorithms (e.g., foranalyte concentration calculation, trending, and/or contributing topotential dosing levels for the subjects). In some embodiments, thetransceiver 101 may store (e.g., in memory 922) any alert and/or alarmconditions detected based on the calculated analyte concentrations.

In some embodiments, the continuous analyte monitoring system 120 maykeep track of an analyte concentration (e.g., blood glucoseconcentration) in the user. In some embodiments, the continuous analytemonitoring system may facilitate user entry of one or more measurablephysiological parameters (e.g., insulin and/or meal bolus and/orexercise regimen) on a mobile medical application. The mobile medicalapplication may be running/executed on (a) the transceiver 101 and/or(b) the display device 102 (e.g., smartphone, receiver, laptop, tablet,notebook, or personal computer) in communication with the transceiver101, analyte sensor 100, and/or activity tracker 110. For example, inone non-limiting embodiment, the mobile medical application may beexecuted by a processor 109 of the display device 102. In someembodiments having a smartphone or other display device 102 incommunication with the transceiver, the communication between thetransceiver 101 and the smartphone or other display device 102 may bewireless communication (e.g., using the Bluetooth wireless communicationstandard) or wired communication, and the smartphone or other displaydevice 102 may receive information (e.g., analyte concentrations) fromthe transceiver 101.

In some embodiments, the continuous analyte monitoring system 120 maycombine analyte concentration information with measurable physiologicalparameters to provide alerts regarding a current or projectedphysiological condition. For example, in some embodiments where theanalyte is glucose, the continuous glucose monitoring system 120 mayfuse glucose concentration information with measurable physiologicalparameters to provide alerts regarding a current or projectedhypoglycemic condition. In some embodiments, the alerts may includepredictive alerts that could be used to prevent a projectedphysiological condition. For instance, in some non-limiting embodiments,predictive alerts could be used to prevent hypoglycemic episodes (e.g.,night time hypoglycemic episodes or in cases of hypoglycemiaunawareness) that are preceded by extended duration of activity detectedusing the accelerometer. For example, the continuous analyte monitoringsystem may provide alerts to the mobile medical application which wouldtrigger a text alert on the smartphone or other display device 102 suchas “No meal was taken following extended activity. Please eat beforegoing to sleep.”

FIG. 3 is a flow chart illustrating an alerting process 300 embodyingaspects of the present invention. In some embodiments, the alertingprocess 300 may include a step 301 of generating acceleration datacorresponding to movement of an accelerometer. In some embodiments, theacceleration data may be generated by one or more accelerometers (e.g.,accelerometer 105 and/or accelerometer 111), which may be located in oneor more of the analyte sensor 100, transceiver 101, display device 102,and activity tracker 111.

In some embodiments, the alerting process 300 may include a step 302 ofgenerating activity information based on the acceleration data. In someembodiments, the activity information may be generated by one or more ofthe transceiver 101 (e.g., by the microcontroller 920 of transceiver101), the display device 102 (e.g., by a mobile medical applicationbeing executed on the processor 109 of the display device 102), and theactivity tracker 111.

In some embodiments, the alerting process 300 may include a step 303 ofgenerating analyte concentration values based on data signals receivedfrom the analyte sensor 100. In some embodiments, the analyteconcentration values may be generated by one or more of the transceiver101 (e.g., by the microcontroller 920 of transceiver 101) and thedisplay device 102 (e.g., by a mobile medical application being executedon the processor 109 of the display device 102). Although, in theembodiment illustrated in FIG. 3, the step 303 of generating analyteconcentration values occurs after steps 301 and 302, this is notrequired, and, in some alternative embodiments, the step 303 may occurbefore or during with one or more of steps 301 and 302.

In some embodiments, the alerting process 300 may include a step 304 ofgenerating an alert for the current or projected physiological conditionor reaction based on one or more of the activity information and theanalyte concentration values. In some embodiments, the alert may begenerated by one or more of the transceiver 101 (e.g., by themicrocontroller 920 of transceiver 101) and the display device 102(e.g., by a mobile medical application being executed on the processor109 of the display device 102).

In some embodiments, an accelerometer (e.g., accelerometer 105) may beplaced inside a printed circuit board (PCB) of the transceiver 101, andthe accelerometer may be used to detect the movements of the user's body(e.g., the user's upper body in an embodiment where the transceiver isworn on the arm or the user's core when the transceiver is worn on theabdomen). In some embodiments, outputs of the accelerometer maycorrespond to accelerations along the X, Y and Z axis. In someembodiments, the outputs may be analog values that have been convertedto digital values by an analog-to-digital converter (ADC). Theaccelerometer outputs may be used to interpret and quantify themovements of the user(s) wearing the transceiver.

FIG. 4 is a flow chart illustrating an activity information generationprocess 400 embodying aspects of the present invention. In somenon-limiting embodiments, the process 400 may be performed in step 302of the alerting process 300. In some embodiments, the activityinformation generation process 400 may include a step 401 of convertingaccelerating data into scalar acceleration values. In some embodiments,the conversion of step 401 may include converting raw data (e.g.,digital values) from the accelerometer to g's (m/sec2). In someembodiments, the conversion of step 401 may include converting theresultant data to a scalar value. In some non-limiting embodiments, theresultant data may be converted to scalar values using the formula shownbelow:

AccScalar=sqrt(X*X+Y*Y+Z*Z)  (Formula 1)

In some embodiments, circuitry (e.g., microcontroller 920) of thetransceiver 101 may carry out the conversion of the accelerometer rawdata to g's and from the g's to the scalar values. However, this is notrequired, and in other embodiments a portion or all of the conversionsmay be carried out elsewhere, such as, for example and withoutlimitation, by the display device 102 (e.g., a smartphone or personalcomputer) and/or by the activity tracker 110. FIG. 5 is a graph showinga non-limiting example of scalar acceleration values (black line) of anaccelerometer over time.

In some embodiments, the process 400 may include a step 403 of comparingscalar acceleration values to one or more activity thresholds. That is,in some embodiments, the continuous analyte monitoring system 120 mayuse the scalar acceleration values to detect abrupt changes inacceleration based on one or more cutoff thresholds. These instances ofhigh changes in acceleration typically correspond to changes in theposition of the body and, thus, activity. Accordingly, in somenon-limiting embodiments, the continuous analyte monitoring system 120may detect activity by detecting when a scalar acceleration valueexceeds the cutoff threshold (i.e., an activity threshold). FIG. 5 showsdetected activities (stars) based on an activity threshold of 0.18 inthe non-limiting example. Although an activity threshold of 0.18 is usedin the embodiment shown in FIG. 5, this is not required, and alternativeembodiments may use one or more different activity thresholds.

In some embodiments, the process 400 may include a step 403 ofgenerating activity information based on the frequency of accelerationvalues that exceed the activity threshold. In some non-limitingembodiments, the step 403 may use the frequency of detected activities(e.g., within a time window) to characterize the activity in theacceleration information into three main categories: noactivity/sedentary, moderate activity, and high activity. FIG. 6 is agraph showing an exemplary classification of the detected activity inthe acceleration information into no activity, moderate activity, andhigh activity categories. Accordingly, FIG. 6 shows the intensity andduration of the physical activity of the user.

In some embodiments, this information about the activity may be (i)provided to the user independently as a graph generated by the mobilemedical application and displayed on a display (e.g., display 108 of thedisplay device 102) and/or (ii) fused with the analyte data fromcontinuous analyte monitoring system for providing predictive alerts ofpossible health condition episodes (e.g., hypoglycemic episodes) beforethey happen. FIG. 7 is a graph showing an example of analytemeasurements (e.g., continuous glucose monitoring system (CGMS)measurements) together with activity monitoring data. The graph may bedisplayed, for example and without limitation, by the display 108 of thedisplay device 102 and/or by the display 924 of the transceiver 101.

In some embodiments, the continuous analyte monitoring system 120 mayadditionally or alternatively use the activity information to detectsleep patterns and/or step counts, which may be provided to the userusing graphs and/or bar plots. In some non-limiting embodiments, thegraphs and/or plots may be, for example and without limitation,generated by a mobile medical application running on processor 109 ofthe display device 102 and displayed by display 108 of the displaydevice 102.

In some non-limiting embodiments, the continuous analyte monitoringsystem 120 may use galvanic or physiologic measurements (e.g.,heartrate, heartbeat, and/or sweating) generated by one or more on-bodyor within body sensors in conjunction with the acceleration datagenerated by the one or more accelerometers to generate the activityinformation and generate the alerts regarding a current or projectedphysiological condition or reaction.

Embodiments of the present invention have been fully described abovewith reference to the drawing figures. Although the invention has beendescribed based upon these preferred embodiments, it would be apparentto those of skill in the art that certain modifications, variations, andalternative constructions could be made to the described embodimentswithin the spirit and scope of the invention.

What is claimed is:
 1. A system comprising: an analyte sensor configuredto generate analyte data; an accelerometer configured to generateacceleration data corresponding to movement of the accelerometer; awearable transceiver comprising a memory, a display device interface,and a controller configured to store the analyte data in the memory withthe acceleration data and date and time information.
 2. The system ofclaim 1, wherein the controller is further configured to cause thedisplay device interface to convey the analyte data, the accelerationdata, and the date and time information to a display device
 3. Thesystem of claim 1, further comprising the display device, wherein thedisplay device is configured to receive the analyte data, theacceleration data, and the date and time information conveyed by thewearable transceiver.
 4. The system of claim 3, wherein the displaydevice is configured to calculate an analyte concentration value usingat least the analyte data.
 5. The system of claim 3, wherein the displaydevice is configured to calculate an analyte concentration value usingat least the analyte data and the acceleration data.
 6. The system ofclaim 3, wherein the display device is configured to generate activityinformation based on the acceleration data.
 7. The system of claim 6,wherein generating the activity information based on the accelerationinformation comprises: converting the acceleration data into scalaracceleration values; comparing the scalar acceleration values to anactivity threshold; and generating the activity information based on afrequency at which the scalar acceleration values exceed the activitythreshold.
 8. The system of claim 7, wherein the display device isconfigured to calculate an analyte concentration value using at leastthe analyte data.
 9. The system of claim 8, wherein the display deviceis configured to calculate an analyte concentration value using at leastthe analyte data and the activity information.
 10. The system of claim8, wherein the display device is configured to display the analyteconcentration value together with the activity information.
 11. Thesystem of claim 8, wherein the display device is configured to display aplot of analyte concentration values and activity information withrespect to time.
 12. The system of claim 8, wherein the display deviceis configured to generate an alert for a current or projectedphysiological condition or reaction based on the analyte concentrationvalue and the activity information.
 13. The system of claim 1, whereinthe wearable transceiver comprises the accelerometer.
 14. The system ofclaim 1, wherein the display device interface comprises an antenna. 15.The system of claim 1, wherein the display device interface comprises awireless communication integrated circuit.
 16. The system of claim 1,further comprising an adhesive patch configured to hold the wearabletransceiver in place on a body of a patient.
 17. A method comprising:using an analyte sensor to generate analyte data; using an accelerometerto generate acceleration data corresponding to movement of theaccelerometer; and using a controller of a wearable transceiver to storethe analyte data with the acceleration data and date and timeinformation in a memory of the wearable transceiver.
 18. The method ofclaim 17, further comprising using the controller of the wearabletransceiver to cause a display device interface of the wearabletransceiver to convey the analyte data, the acceleration data, and thedate and time information to a display device.
 19. The method of claim18, further comprising using the display device to receive the analytedata, the acceleration data, and the date and time information conveyedby the wearable transceiver.
 20. The method of claim 19, furthercomprising using the display device to calculate an analyteconcentration value using at least the analyte data.
 21. The method ofclaim 19, further comprising using the display device to calculate ananalyte concentration value using at least the analyte data and theacceleration data.
 22. The method of claim 19, further comprising usingthe display device to generate activity information based on theacceleration data.
 23. The method of claim 22, wherein generating theactivity information based on the acceleration information comprises:converting the acceleration data into scalar acceleration values;comparing the scalar acceleration values to an activity threshold; andgenerating the activity information based on a frequency at which thescalar acceleration values exceed the activity threshold.
 24. The methodof claim 22, further comprising using the display device to calculate ananalyte concentration value using at least the analyte data.
 25. Themethod of claim 24, wherein the display device calculates the analyteconcentration value using at least the analyte data and the activityinformation.
 26. The method of claim 24, further comprising using thedisplay device to display the analyte concentration value together withthe activity information.
 27. The method of claim 24, further comprisingusing the display device to display a plot of analyte concentrationvalues and activity information with respect to time.
 28. The method ofclaim 24, further comprising using the display device to generate analert for a current or projected physiological condition or reactionbased on the analyte concentration value and the activity information.29. The method of claim 17, wherein the wearable transceiver comprisesthe accelerometer.